Bio-Dia：Amlodipine Besylate has been rejected again.
Following the failure of a Category 2.2 improved drug application for the same product, Zhejiang Baidai’s improved new drug, Amlodipine Besylate Granules, has once again received a rejection notice, shattering the industry’s wishful thinking. Amlodipine Besylate was originally developed by Pfizer in the United States and is a classic antihypertensive drug. It was first approved in the UK in 1990, received FDA approval the following year, and entered the Chinese market in 1993, where it quickly established itself as a first-line clinical drug. According to data, total sales of related formulations of this drug in the terminal hospital market exceeded RMB 3.9 billion in 2025, demonstrating its significant market influence.
After the patent for the original drug expired, numerous domestic generic drug manufacturers flooded into this space. For the tablet formulation alone, there are currently 98 approved license numbers, with more than 60 companies having passed or being deemed to have passed the consistency evaluation. Despite multiple rounds of centralized procurement that have driven the price of ordinary tablets to low levels, the drug’s market position remains unshakable due to its stable efficacy and high safety profile.
To avoid the low-price competition of centralized procurement and escape the homogeneous red ocean, many pharmaceutical companies have set their sights on the Category 2.2 improved new drug pathway. They attempt to repackage products as “new drugs” and reprice them at higher levels simply by changing the dosage form or adjusting the strength, thereby obtaining higher profits. This pathway was once regarded as an industry “shortcut” to circumvent centralized procurement.
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